Brain Enhancement Training Towards Elders Resilience to Aging (BETTER Aging)

Brain Enhancement Training Towards Elders Resilience to Aging (BETTER Aging)

This study is a parallel arm, double-blind, randomized, controlled clinical trial to assess the efficacy of an experimental software program designed to improve cognitive functions versus a computer-based software control. Both the study and the software being investigated meet the criteria of Non-Significant Risk.

Study Overview

• Status: Completed
• Conditions: Age-related Cognitive Decline
• Intervention / Treatment: Other: Computerized Plasticity-Based Adaptive Cognitive Training; Other: Commercially available computerized training

Detailed Description

The primary objective of this study is to evaluate the effects of the experimental treatment (cognitive training) further outlined in this protocol on the cognitive abilities (e.g., processing speed, attention, working memory, and executive function), brain functionality, functional status and quality of life of individuals with age-related cognitive decline as compared to a computer-based active control.

• Study Type: Interventional
• Enrollment (Actual): 147
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa
  • Texas
    • Dallas, Texas, United States, 75235
      • University of Texas at Dallas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Participant must be 65 years of age or older
• Participant must be a fluent English speaker
• Participant must have adequate sensorimotor capacity to perform the program, including visual capacity adequate to read from a computer screen at a normal viewing distance, auditory capacity adequate to understand normal speech, and motor capacity adequate to control a computer mouse
• Participant must not have evidence of dementia as indicated by the Montreal Cognitive Assessment (MoCA)

Exclusion Criteria:

• Participant with any medical illnesses, injuries or conditions predisposing to imminent functional and/or cognitive decline
• Participant requiring caregiver assistance in dressing/personal hygiene
• Participant with severe visual deficits (including visual neglect, partial field cuts, anopias) and/or severe hearing deficit that would prevent use of the computerized treatment program
• Participant with recent participation of computer-delivered cognitive training within 2 years of consent
• Participant with claustrophobia or any other contraindication to MRI scanning
• Participant with inability to complete a 1-hour MRI
• Pregnant women
• Participant with any implanted devices above the waist (e.g., cardiac pacemaker or auto-defibrillators, neural pacemaker, aneurysm clips, cochlear implant, metallic bodies in the eye or central nervous system, any form of wires or metal devices that may concentrate radio frequency fields)
• Participants with active suicidal ideation with specific plan and intent or suicide-related behaviors within 2 months of consent as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Treatment; Computerized plasticity-based adaptive cognitive training requiring a total maximum of 50 treatment sessions, up to 5 sessions per week, 42 minutes per session.	Other: Computerized Plasticity-Based Adaptive Cognitive Training; Forty-two minutes of training on computerized exercises that targets processing speed, memory and attention.
Active Comparator: Active Comparator; Commercially available computerized training requiring a total maximum of 50 treatment sessions, up to 5 sessions per week, 42 minutes per session.	Other: Commercially available computerized training; Forty-two minutes of training on computerized, casual video games.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in performance on global cognitive composite score	Change in performance on global cognitive composite score based on the average of all normalized assessment measures.	At 3 months and at 9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in performance on processing speed composite score	Change in performance on processing speed will be measured using the composite score created by averaging the z-scores of Pattern Comparison, Letter Comparison, and Digit Symbol Coding tasks.	At 3 months and at 9 months
Change in brain function	Change in resting state functional connectivity will be measured by resting State T2*weighted EPI-BOLD, a 10-minute task-free BOLD contrast sequence consisting of 300 volumes (TR=2000 ms/TE=30ms) at 3.4mm3 in-plane resolution and 3mm slice thickness. Participants will be instructed to keep their eyes open and maintain attention on a central gray fixation cross on a black screen.	At 3 months
Change in brain structure	3D T1-Weighted multi-echo MPRAGE. Morphometric analyses will be based on this MRI sequence (not accelerated because the reliability of acceleration for multi-site studies has not yet been established). We will achieve spatial resolution of 1 x 1 x 1 mm voxels.	At 3 months
Change in task-related brain activation	Change in functional connectivity and brain activation will be measured while performing Task Switch.	At 3 months
Change in functional performance	Between-group magnitude of change in sum time of all tasks in the Timed Instrumental Activities of Daily Living (TIADL). Higher scores indicate greater impairment in functional performance.	At 3 months and at 9 months
Change in Depressive Symptoms	Between-group magnitude of change in sum score using the self-report measure, Center for Epidemiologic Studies Depression Scale (CES-D). The scoring range is 0-60. Higher scores indicate the presence of more symptomatology.	At 3 months and at 9 months
Change in performance on memory	Change in performance on memory will be measured using the composite score created by averaging the z-scores of Selective Reminding Task, Face Name Task, and Visual Short Term Memory tasks.	At 3 months and at 9 months
Change in performance on executive function	Change in performance on executive function will be measured using the composite score created by averaging the z-scores of Flanker Task, N-Back Task and Task Switch (fMRI task).	At 3 months and at 9 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Stress	Between-group magnitude of change in sum score using the self-report measure, Perceived Stress Scale (PSS-10). The scoring range is 0-40. Higher scores indicate higher perceived stress.	At 3 months and at 9 months
Change in Self-Efficacy	Between-group magnitude of change in sum score using the self-report measure, Self-Efficacy Survey. The scoring range is 10-40. Lower scores indicate lower self efficacy.	At 3 months and at 9 months
Change in Life Satisfaction	Between-group magnitude of change in sum score using the self-report measure, Life Satisfaction Scale. The scoring range is 5-35. Lower scores indicate lower life satisfaction.	At 3 months and at 9 months
Change in Physical Activity	Change in total score based on weekly self-report dairy about physical activity during training period.	At 3 months
Change in Diet	Change in total score based on weekly self-report dairy about diet during training period.	At 3 months
Change in Social Activity	Change in total score based on weekly self-report dairy about social activity during training period.	At 3 months
Change in Sleep	Change in total score based on weekly self-report dairy about sleep during training period.	At 3 months
Change in Functional Abilities	Change in total score based on weekly self-report dairy about functional abilities during training period.	At 3 months

Collaborators and Investigators

• Sponsor: Posit Science Corporation
• Collaborators: University of Iowa; National Institute on Aging (NIA); The University of Texas at Dallas
• Investigators: Principal Investigator: Hyun Kyu Lee, PhD, Posit Science Corporation

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Actual): July 16, 2021
• Study Completion (Actual): July 16, 2021

Study Registration Dates

• First Submitted: June 21, 2017
• First Submitted That Met QC Criteria: June 21, 2017
• First Posted (Actual): June 23, 2017

Study Record Updates

• Last Update Posted (Actual): October 31, 2023
• Last Update Submitted That Met QC Criteria: October 27, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: PSC-0605-17

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No